Category: drug-approval

In our previous article, we covered FDA new drug approvals for 2018. In the present article, we look at patent filings, litigation, regulatory and clinical data, related to these drug approvals, as a case study of fusing complementary data sources to provide comprehensive pharma competitive intelligence.

The pharma industry and US FDA will reflect on a record breaking 2018 for drug approvals. The Center for Drug Evaluation and Research (CDER) approved 59 new drugs last year which is a significant increase from previous years (FIG. 1; area plots). In the last 10 years, the FDA has approved 271 novel drugs and 85 biologics (FIG. 1, line plots). The new approvals for 2018 includes 42 new molecular entities and 17 new biologics. Small molecules dominate the list contributing to 64% of the approved drugs, while antibodies represent another 20%. There was a 40% increase in approvals of cancer therapies as compared to 2017. Increased approval trends were observed towards the end of the year with the last quarters accounting for more than 70% of the approved drugs. Oral dosage forms, such as tablets and capsules, accounted for greater than 80% of approved drugs (FIG. 2).